V-Go Disposable Insulin Delivery 8560-9400-03
GUDID 40385609400030
20 Units/24 hour basal rate and up to 36 Units of on-demand bolus dosing in 2-Unit increments
VALERITAS, INC.
Ambulatory insulin infusion pump, mechanical Ambulatory insulin infusion pump, mechanical Ambulatory insulin infusion pump, mechanical Ambulatory insulin infusion pump, mechanical Ambulatory insulin infusion pump, mechanical Ambulatory insulin infusion pump, mechanical Ambulatory insulin infusion pump, mechanical Ambulatory insulin infusion pump, mechanical Ambulatory insulin infusion pump, mechanical Ambulatory insulin infusion pump, mechanical Ambulatory insulin infusion pump, mechanical Ambulatory insulin infusion pump, mechanical Ambulatory insulin infusion pump, mechanical Ambulatory insulin infusion pump, mechanical Ambulatory insulin infusion pump, mechanical Ambulatory insulin infusion pump, mechanical Ambulatory insulin infusion pump, mechanical Ambulatory insulin infusion pump, mechanical Ambulatory insulin infusion pump, mechanical Ambulatory insulin infusion pump, mechanical Ambulatory insulin infusion pump, mechanical Ambulatory insulin infusion pump, mechanical Ambulatory insulin infusion pump, mechanical Ambulatory insulin infusion pump, mechanical Ambulatory insulin infusion pump, mechanical Ambulatory insulin infusion pump, mechanical Ambulatory insulin infusion pump, mechanical Ambulatory insulin infusion pump, mechanical Ambulatory insulin infusion pump, mechanical Ambulatory insulin infusion pump, mechanical Ambulatory insulin infusion pump, mechanical Ambulatory insulin infusion pump, mechanical Ambulatory insulin infusion pump, mechanical Ambulatory insulin infusion pump, mechanical Ambulatory insulin infusion pump, mechanical Ambulatory insulin infusion pump, mechanical Ambulatory insulin infusion pump, mechanical Ambulatory insulin infusion pump, mechanical Ambulatory insulin infusion pump, mechanical Ambulatory insulin infusion pump, mechanical Ambulatory insulin infusion pump, mechanical Ambulatory insulin infusion pump, mechanical Ambulatory insulin infusion pump, mechanical Ambulatory insulin infusion pump, mechanical Ambulatory insulin infusion pump, mechanical Ambulatory insulin infusion pump, mechanical Ambulatory insulin infusion pump, mechanical Ambulatory insulin infusion pump, mechanical| Primary Device ID | 40385609400030 |
| NIH Device Record Key | 08706668-2fda-4aed-9ab5-04c663a16612 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | V-Go Disposable Insulin Delivery |
| Version Model Number | V-Go 20 |
| Catalog Number | 8560-9400-03 |
| Company DUNS | 800531092 |
| Company Name | VALERITAS, INC. |
| Device Count | 30 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 1-866-881-1209 |
| xx@xx.xx | |
| Phone | 1-866-881-1209 |
| xx@xx.xx | |
| Phone | 1-866-881-1209 |
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| Phone | 1-866-881-1209 |
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| Phone | 1-866-881-1209 |
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| Phone | 1-866-881-1209 |
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| Phone | 1-866-881-1209 |
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| Phone | 1-866-881-1209 |
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| Phone | 1-866-881-1209 |
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| Phone | 1-866-881-1209 |
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| Phone | 1-866-881-1209 |
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| Phone | 1-866-881-1209 |
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| Phone | 1-866-881-1209 |
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| Phone | 1-866-881-1209 |
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| Phone | 1-866-881-1209 |
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| Phone | 1-866-881-1209 |
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| Phone | 1-866-881-1209 |
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| Phone | 1-866-881-1209 |
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| Phone | 1-866-881-1209 |
| xx@xx.xx | |
| Phone | 1-866-881-1209 |
| xx@xx.xx | |
| Phone | 1-866-881-1209 |
| xx@xx.xx | |
| Phone | 1-866-881-1209 |
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| Phone | 1-866-881-1209 |
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| Phone | 1-866-881-1209 |
| xx@xx.xx | |
| Phone | 1-866-881-1209 |
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| Phone | 1-866-881-1209 |
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| Phone | 1-866-881-1209 |
| xx@xx.xx | |
| Phone | 1-866-881-1209 |
| xx@xx.xx | |
| Phone | 1-866-881-1209 |
| xx@xx.xx | |
| Phone | 1-866-881-1209 |
| xx@xx.xx | |
| Phone | 1-866-881-1209 |
| xx@xx.xx | |
| Phone | 1-866-881-1209 |
| xx@xx.xx | |
| Phone | 1-866-881-1209 |
| xx@xx.xx | |
| Phone | 1-866-881-1209 |
| xx@xx.xx | |
| Phone | 1-866-881-1209 |
| xx@xx.xx | |
| Phone | 1-866-881-1209 |
| xx@xx.xx | |
| Phone | 1-866-881-1209 |
| xx@xx.xx | |
| Phone | 1-866-881-1209 |
| xx@xx.xx | |
| Phone | 1-866-881-1209 |
| xx@xx.xx | |
| Phone | 1-866-881-1209 |
| xx@xx.xx | |
| Phone | 1-866-881-1209 |
| xx@xx.xx | |
| Phone | 1-866-881-1209 |
| xx@xx.xx | |
| Phone | 1-866-881-1209 |
| xx@xx.xx | |
| Phone | 1-866-881-1209 |
| xx@xx.xx | |
| Phone | 1-866-881-1209 |
| xx@xx.xx | |
| Phone | 1-866-881-1209 |
| xx@xx.xx | |
| Phone | 1-866-881-1209 |
| xx@xx.xx | |
| Phone | 1-866-881-1209 |
| xx@xx.xx |
Device Dimensions
| Total Volume | 0.56 Milliliter |
| Total Volume | 0.56 Milliliter |
| Total Volume | 0.56 Milliliter |
| Total Volume | 0.56 Milliliter |
| Total Volume | 0.56 Milliliter |
| Total Volume | 0.56 Milliliter |
| Total Volume | 0.56 Milliliter |
| Total Volume | 0.56 Milliliter |
| Total Volume | 0.56 Milliliter |
| Total Volume | 0.56 Milliliter |
| Total Volume | 0.56 Milliliter |
| Total Volume | 0.56 Milliliter |
| Total Volume | 0.56 Milliliter |
| Total Volume | 0.56 Milliliter |
| Total Volume | 0.56 Milliliter |
| Total Volume | 0.56 Milliliter |
| Total Volume | 0.56 Milliliter |
| Total Volume | 0.56 Milliliter |
| Total Volume | 0.56 Milliliter |
| Total Volume | 0.56 Milliliter |
| Total Volume | 0.56 Milliliter |
| Total Volume | 0.56 Milliliter |
| Total Volume | 0.56 Milliliter |
| Total Volume | 0.56 Milliliter |
| Total Volume | 0.56 Milliliter |
| Total Volume | 0.56 Milliliter |
| Total Volume | 0.56 Milliliter |
| Total Volume | 0.56 Milliliter |
| Total Volume | 0.56 Milliliter |
| Total Volume | 0.56 Milliliter |
| Total Volume | 0.56 Milliliter |
| Total Volume | 0.56 Milliliter |
| Total Volume | 0.56 Milliliter |
| Total Volume | 0.56 Milliliter |
| Total Volume | 0.56 Milliliter |
| Total Volume | 0.56 Milliliter |
| Total Volume | 0.56 Milliliter |
| Total Volume | 0.56 Milliliter |
| Total Volume | 0.56 Milliliter |
| Total Volume | 0.56 Milliliter |
| Total Volume | 0.56 Milliliter |
| Total Volume | 0.56 Milliliter |
| Total Volume | 0.56 Milliliter |
| Total Volume | 0.56 Milliliter |
| Total Volume | 0.56 Milliliter |
| Total Volume | 0.56 Milliliter |
| Total Volume | 0.56 Milliliter |
| Total Volume | 0.56 Milliliter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 10 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00385600000200 [Unit of Use] |
| GS1 | 00385609400032 [Primary] |
| GS1 | 40385609400030 [Package] Contains: 00385609400032 Package: carton [4 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K103825
FDA Product Code
| LZG | Pump, Infusion, Insulin |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-09-12 |
| Device Publish Date | 2016-05-24 |
On-Brand Devices [V-Go Disposable Insulin Delivery]
| 10385609600033 | 20 Units/24 hour basal rate and up to 36 Units of on-demand bolus dosing in 2-Unit increments |
| 10385609600026 | 30 Units/24 hour basal rate and up to 36 Units of on-demand bolus dosing in 2-Unit increments |
| 10385609600019 | 40 Units/24 hour basal rate and up to 36 Units of on-demand bolus dosing in 2-Unit increments |
| 40385609400030 | 20 Units/24 hour basal rate and up to 36 Units of on-demand bolus dosing in 2-Unit increments |
| 00385609400025 | 30 Units/24 hour basal rate and up to 36 Units of on-demand bolus dosing in 2-Unit increments |
| 40385609400016 | 40 Units/24 hour basal rate and up to 36 Units of on-demand bolus dosing in 2-Unit increments |
Trademark Results [V-Go Disposable Insulin Delivery]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 V-GO DISPOSABLE INSULIN DELIVERY 77752697 4105936 Live/Registered |
Valeritas, Inc. 2009-06-04 |
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